ChinaCourt CasesInvalidationInventionsPharma
19 November 2018

Can Post Filing Data Overcome Inventive Step in China?

Since 2010, the Patent Re-examination Board (PRB) has published the top 10 patent invalidation cases of the year in April of each year. The selection criteria are high social concern, significant impact on the related industry, or involve difficult legal issues and important examination criteria. Below is one of the top 10 cases that discusses post filing data in China patents.

Post Filing Data in China

Can post-filing data showing unexpected technical effect be used to overcome inventive step if the specification contains no data but asserts the unexpected technical effect?
In short, the answer is no, post-filing data cannot be used to overcome inventive step even if the idea was asserted if the original data was not in the application. Novartis’s Chinese patent (201110029600.7) claimed the combination of AT 1-antagonist valsartan and NEP inhibitor Sacubitril. The specification asserted that the combination of the two drugs had synergistic effect, yet provided no data at the time of filing. The PRB sided with petitioner Dai Jinliang and argued that one of skill in the art could not predict that the combination would be synergistic without experimental data. In other words, applicants had not solved the technical problem of providing a pharmaceutical combination with synergistic effects. At most, applicants had provided a pharmaceutical composition for treating hypertension. In January of 2018, the PRB declared that the Novartis patent was invalid. In our experience, if experimental data is in the application as filed but another piece of prior art is cited during prosecution, the applicant may submit post-filing data showing results of comparison studies with the newly discovered art, provided that the original data for applicant’s invention was already disclosed in the application as filed. About the Author
Jennifer Che, J.D. is a US Patent Attorney and Vice President and Partner at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau. [email protected] This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.

Other Articles

Twice the Trouble: Unraveling a Single Case of Dual Patent and Trademark Infringement

9 January 2024
Can a rights holder sue the same infringer separately based on one single infringing act that infringes both trademark and patent rights? An interesting case this year from China’s Supreme People’s Court that addresses this specific issue ((2023)最高法知民终235号). Beijing Run De Hong Tu Technology Development Co., Ltd. (“Run De Hong Tu”) sued an individual named […]

The Latest on Post-Filing Data in China’s Patent Law

29 April 2020
Post-filing data can sometimes be the crucial difference between a patent allowance and a final rejection. The reasons are endless why important data may not have been included in the original patent application as filed. Time and budget may have been insufficient to generate data over the full scope of the claims at the time […]

China Releases Draft Implementation Guidelines for the Drug Administration Law

2 June 2022
The latest draft implementation guidelines for China’s Drug Administration Law (“Guidelines”) are out and open for comment. Previously, the new implementation measures for early dispute resolution mechanisms for drug patents (“Patent Linkage Measures”) came into effect on July 4, 2021. The Guidelines indicate that the final approval of generic chemical drug applications for marketing approval […]

AI is magical but NOT magic! Be specific in your AI patents!

9 January 2025
What is the standard of sufficient disclosure for AI-related patents: A case study in China The rapid growth of AI patent applications present significant challenges to existing patent application and examination practices. One of them is satisfying the requirement for sufficient disclosure. The following case was featured in the 2023 CNIPA Compilation of Key Decisions […]

Our Past Events

Top crossarrow-right